| Trial ID: | L3377 |
| Source ID: | NCT02562326
|
| Associated Drug: |
Biochaperone Insulin Lispro
|
| Title: |
A Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: BioChaperone insulin lispro|DRUG: Humalog®
|
| Outcome Measures: |
Primary: Pharmacodynamics: ΔAUCBG 0-2h, Incremental Area Under Blood Glucose concentration-time Curve from 0-2 hours after a meal (comparison between BioChaperone insulin lispro and insulin lispro), 2 hours|Pharmacokinetics: AUClis 0-30min, Area Under the serum insulin Lispro concentration-time Curve 0-30 minutes (comparison between BioChaperone insulin lispro and insulin lispro), 30 minutes | Secondary: AUClisp_0-6h, Area Under the serum insulin Lispro concentration-time Curve from 0-6 hours after bolus dose, up to 6 hours|Cmax_lisp, Maximum serum insulin lispro Concentration, up to 6 hours|tmax_lisp, Time to maximum observed serum insulin lispro concentration, up to 6 hours|CmaxBG, Maximum Blood Glucose after an individualised standard meal, up to 6 hours|AUCBG_0-6h, Area Under the Curve under the Blood Glucose concentration time curve from 0-6 hours, up to 6 hours|Adverse Events, Number of Adverse Events, up to 8 weeks|Local tolerability, Record of injection site reaction, up to 8 weeks
|
| Sponsor/Collaborators: |
Sponsor: Adocia | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
51
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-09
|
| Completion Date: |
2016-01
|
| Results First Posted: |
|
| Last Update Posted: |
2016-04-29
|
| Locations: |
Profil Mainz GmbH & Co.KG, Mainz, 44116, Germany|Profil GmbH, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02562326
|
